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CompletedNCT03455153PALI-COPDUpdated Oct 9, 2018

Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

An observational study in COPD, sponsored by University of Lincoln. Completed at 3 sites in United Kingdom. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by University of Lincoln · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
40 Years to 90 Years
Sex
All
01

Study summary

COPD is characterised by irreversible airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response. This inflammation can be amplified with flare-ups that are commonly seen in COPD patients. Pulmonary rehabilitation is one of the most effective methods of managing chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation has been seen to induce improvements in functional capacity and quality.

In healthy individuals, exercise has been shown to induce an anti-inflammatory response when performed regularly. However, the effects of exercise on inflammation in COPD are unclear. Our initial CIMPRES-COPD study has looked into the effects of short-term exercise, as part of pulmonary rehabilitation, on inflammation. However, this trial will examine the inflammatory response in COPD patients who are most active following pulmonary rehabilitation against those who are least active.

This study will split participants into 2 groups according to physical activity level following pulmonary rehabilitation. We will recruit 40 COPD patients who provided a sample in the initial CIMPRES-COPD study to explore inflammatory responses in those who are most active and least active. By better understanding the mechanisms of how long-term physical activity levels affects inflammation in COPD, we could design better interventions to increase physical activity levels following pulmonary rehabilitation.

02

Conditions studied

  • COPD

Keywords

  • Pulmonary Rehabilitation
  • Neutrophils
03

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.

Inclusion criteria

  • Patients diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio \<0.70 and FEV\<80%)
  • Previously enrolled on pulmonary rehabilitation providing at least one sample for the CIMPRES-COPD trial.

Exclusion criteria

Exclusion Criteria:

  • Any unstable ongoing cardiovascular events.
  • Other active inflammatory conditions (e.g. rheumatoid arthritis, cancer).
  • Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Most active

    COPD patients with higher physical activity levels as defined by daily step counts.

    Other: Physical activity monitoring

  • Least active

    COPD patients with lower physical activity levels as defined by daily step counts.

    Other: Physical activity monitoring

Interventions

  • OtherPhysical activity monitoring

    COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.

05

What researchers measure

Primary outcomes

  1. Cytokines

    Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)

    Time frame: May 2018 - August 2018

Secondary outcomes

  1. Leukocyte count

    Changes in total and differential leukocyte count in all participants (10\^9.L-1)

    Time frame: May 2018 - August 2018

  2. Cell function

    Changes in function of the following cells: myeloperoxidase, neutrophil elastase, MMP-8, MMP-9, TNF-a in the plasma of all participants using ELISA's (mg/L)

    Time frame: May 2018 - August 2018

  3. Cell sensitivity to corticosteroids

    Changes in cell sensitivity to corticosteroids and forskolin in all participants (expressed as fold increase from not treated samples)

    Time frame: May 2018 - August 2018

06

Study locations

3 sites
  • Lindum Medical Practice
    Lincoln, Lincolnshire LN2 2JP, United Kingdom
  • Nettleham Medical Practice
    Lincoln, Lincolnshire LN2 2RS, United Kingdom
  • Birchwood Medical Practice
    Lincoln, Lincolnshire LN6 0QQ, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455153
Lead sponsor
University of Lincoln
Collaborators
National Health Service, United Kingdom
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
May 2, 2018
Primary completion
Oct 2, 2018
Completion
Oct 2, 2018
Last update
Oct 9, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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